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CompletedNCT06709443PPIAUpdated Dec 10, 2024

Effect of Parental Presence on Anxiety of Children During Induction of Anesthesia

An observational study in Anxiety and Preoperative Anxiety, sponsored by Liaquat National Hospital & Medical College. Completed at 1 site in Pakistan. Open to participants aged 5 Years to 10 Years. Per ClinicalTrials.gov, last updated 2024-12-10.

Sponsored by Liaquat National Hospital & Medical College · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
75
Ages
5 Years to 10 Years
Sex
All
01

Study summary

Anxiety is when children feel scared, worried, or nervous before or during anesthesia induction. This can happen because they don't know what's happening, are scared of the hospital or medical equipment, or are worried about being separated from their parents.

When parents are present, they can:

  • Provide emotional support and reassurance
  • Distract the child from scary things
  • Help the child feel more calm and safe This can help reduce the child's anxiety levels.

When parents are not present, children may feel:

  • More scared and anxious
  • Alone and unsupported
  • More worried about what's happening This can increase the child's anxiety levels. we can prepare children and parents beforehand about what will happen
  • Allow parents to be present during anesthesia induction
  • Use distraction techniques like toys or videos
  • Use gentle and calm anesthesia induction techniques By doing these things, we can help reduce anxiety in children and make the experience less scary for them.
Read the detailed description

Induction of pediatric anesthesia represents a highly stressful event for children, often resulting in preoperative anxiety that can impair the child's perioperative experience and result in adverse postoperative outcomes. It has been proposed that parental presence during induction of anesthesia Preoperative anxiety is linked to postoperative maladaptive behaviors, such as pain following surgery, insomnia, conflicts between the child and his parent, separation anxiety, increased urinary frequency during the night, reduced appetite, lack of interest, agitation, and alienation.may be a non-pharmacologic intervention to reduce children's anxiety. In patients with extreme anxiety, unfavorable postoperative behaviors after anesthesia induction are likely to result in long-term issues, which adversely affect the process of recovery, and also develop a feeling of inadequate care. Parental presence at anesthesia induction is the interaction that takes place in the induction room during the course of anesthesia induction between the child, parent, anesthesiologist, and perioperative nurses.

02

Conditions studied

  • Anxiety
  • Preoperative Anxiety

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Keywords

  • Pre-operative anxiety,
  • Minor surgery,
  • parental presence during induction of anesthesia
  • modified Yale Preoperative Anxiety Scale
03

In context

Anxiety Disorders

4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.

This study's enrollment of 75 is below the median of 150 across 606 observational studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Liaquat National Hospital & Medical College is the lead sponsor of 33 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

A group of patients selected from a surgical day care units and wards who presented for minor elective surgical procedures.

Inclusion criteria

  • Pediatric patients
  • aged 5-10 years
  • minor surgery
  • duration \<1 hour
  • ASA 1 and ASA 2 patients

Exclusion criteria

Exclusion Criteria:

  • Patients and attendant refusal
  • Emergency surgeris
  • Renal insuffciency
  • Age less than 5 and more than 10 years
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
75 participants (actual)
Target follow-up
35 Days
Patient registry
Yes

Groups and cohorts

  • PPIA: children anesthetized in the presence of parents

    PPIA: Children induced during the presence parents to assess the level of anxiety while aneshetizing.

  • Control group

    Control Group: children induced without the parental presence to assess level of anxiety during anesthitizing.

06

What researchers measure

Primary outcomes

  1. Anxiety

    Modified yale preoperative anxiety scale (myPAS) assess activity, vocaliztion and Emotional expressivity andstate of apparent arousal. score 4 to 18 4 means no anxiety and 18 means highly anxious

    Time frame: minimum 2 to 3 minutes during Induction of anesthesia

07

Study locations

1 site
  • Liaquat National Hospital and Medical College
    Karachi, Sindh, Pakistan
08

References and documents

Individual participant data

Plan to share: No — 1. \*Patient confidentiality\*: Sharing IPD could compromise patient confidentiality and anonymity, potentially harming participants or their families. 2. \*Sponsor's intellectual property\*: Clinical trial sponsors may consider IPD as their intellectual property, and sharing it could compromise their commercial interests. 3. \*Competitive advantage\*: Sharing IPD could provide competitors with valuable insights, potentially eroding the sponsor's competitive advantage. Data quality and validation\*: IPD may require additional validation and quality control checks before sharing, which can be time-consuming and resource-intensive. 4. \*Methodological limitations\*: Sharing IPD without proper context and methodology information may lead to misinterpretation or misuse of the data. 5. Informed consent\*: Participants may not have provided informed consent for their data to be shared, which could raise ethical concerns.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06709443
Lead sponsor
Liaquat National Hospital & Medical College
Responsible party
Ghulam Fatima (Principal Investigator, Liaquat National Hospital & Medical College) — Principal investigator
First posted
Nov 29, 2024
Start date
Jan 1, 2024
Primary completion
Jun 10, 2024
Completion
Jun 10, 2024
Last update
Dec 10, 2024

Study contacts

Ghulam Fatima Dr Ghulam Fatima
principal investigator · Liaquat National Hospital and Medical College

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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